Manager, Regulatory Affairs Chemistry Manufacturing & Controls; CMC

Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC)

• Full‑time
• Salary Min: 109,500
• Salary Max: 208,500
• Workday Global Grade: 18
• Compensation: USD 109,500 - USD 208,500 - yearly

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio.

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) – Biologics Product Lead works with internal and external partners to deliver products to patients. The role prepares CMC regulatory strategies that enable first‑pass approvals under limited management supervision. It develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations, with limited supervision. The Manager builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations, and represents RA CMC on product development and life‑cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.

• Prepare CMC regulatory product strategies and submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations, with limited supervision.
• Analyze and interpret information that impacts regulatory decisions, and seek expert advice and technical support as required.
• Review and revise regulatory submission documentation to present data and strategy effectively to regulatory agencies, with limited supervision.
• Respond to global regulatory information requests, with limited supervision.
• Develop strategies for CMC‑related agency interactions and manage preparation of agency meeting requests and information packages, under limited supervision.
• Manage products and change control, analyze and approve manufacturing change records with limited supervision.
• Represent CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams for assigned projects; negotiate and influence team members with support of management to maximize chances for first‑pass approval of regulatory submissions and stay abreast of regulatory procedures and changes in the external regulatory environment.
• Analyze legislation, regulation and guidance and provide analysis to the organization, under limited supervision.
• Contribute to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager and participate in initiatives internal to RA CMC.
• Act as a formal or informal mentor to others.
• This position will work a hybrid schedule (3 days in office) from the Abb Vie Lake County, IL;
  Irvine, CA or Waltham, MA headquarters.

Significant Work

Activities:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day) is required.

• Required
  
  Education:
  
  Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• Preferred Education:
  
  Relevant advanced degree preferred. Certification a plus.
• Required Experience:
  
  6 years’ biopharmaceutical or related industry experience.
• Preferred Experience:
  
  6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs.
• Experience working in a complex and matrix environment.
• Strong oral and written communication skills.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting. Individual compensation paid within this range will depend on many factors including geographic location.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long‑term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico applicants seeking a reasonable accommodation, learn more.